Joel Mayor Lorán
OUR scientists have developed technology in Cuba to manufacture Oseltamivir, the drug now being used to treat victims of the A H1N1 flu virus. In 2009 they completed the process of testing and registering the product.
According to Saul Padron, doctor of pharmacy, and deputy director for Complex Technologies at the Center for Pharmaceutical Research and Development, (CIDEM), more than 80% of the medicines circulating in Cuba are produced on the island.
“It isn’t just this antiviral, state policy is to guarantee broad patient access to medicines.”
The CIDEM emerged with the idea of replacing imported drugs. To date, it has registered more than 700 medications, which involves considerable savings in hard currency. But even more important are the lives saved and our satisfaction with product effectiveness.
When the pandemic began, the antiviral to fight it (Tamiflu) disappeared from the shelves in many countries. Prices went up: from four euros per capsule (10 are prescribed for treatment) to 6.90 euros at present.”
With a degree in Nuclear Chemical Technology from the Russian university named after Dmitri Ivanovich Mendeleiev, Saul is project director of antiviral medicines in the institution located in the West Havana Scientific Complex.
“Developing Oseltamivir was hard work, but we did it with love and much cohesion among pharmacists, chemists, biochemists, engineers; all of us who worked on it, in anticipation of what could happen.
“The national leadership kept abreast with every step: acquiring the raw materials, precise coordination and during the final stage, where we knew that it wasn’t just a ‘maybe.’ All of that effort was a marvelous experience.
“We knew the benefits of that hard work but, at the same time, we hoped not to have to apply all those calculations. However, it was necessary and we are happy to know that we completed the task in time.”
While Tamiflu, which the country has imported to fight the A H1N1 flu virus, was made for adults, the Cuban researchers also provided pediatric doses, which include an oral suspension for infants.
The CIDEM staff didn’t hesitate to work Saturdays and Sundays to fill medicine bottles with Oseltamivir powder for newborns. “By doing that we avoided doctors having to break open the capsules and weigh precise amounts for their youngest patients.”
Samuel, his baby of barely eight months, was born precisely in the final stage of the development of anti-A H1N1 flu drug. Those were hours shared between the center and home, and moreover, his wife and other children are well aware that every victory requires dedication.
The algorithm for arriving at Oseltamivir, as in the case of other products, implied different tests and studies, from the moment of acquiring the raw materials and confirming their quality.
While the formulation and ingredient analysis are crucial phases, so are complementary studies, acceleration development, and presentation of the sanitary file for product registration and industrial production.
Of course, each stage is distinguished by research and quality control. The CIDEM has gained prestige, for its dedication and precision. That is also due to its development of anti-retrovirals to treat HIV/AIDS (some that have won national prizes for technological innovation). And, if that is not enough, it is producing cytostatic (tumor suppressing) drugs in its units.
THE EFFECTIVE DOSE
NOVATEC Laboratories, also in the capital’s Scientific Complex, is manufacturing Oseltamivir at industrial scale, as well as anti-retroviral, high blood pressure medication among 45 other medicines on file, in tablet and capsule form.
Components in powder form are weighed according to the formula given them by their colleagues. The ingredients are mixed to form granules, which are placed into a hard gelatin capsule and from there placed in pre-formed packs of 10 units each.
The design of the modern plant integrates its production lines in a vertical technological flow, with product movement operating on the force of gravity.
However, none of this would be possible without the human input, involving a wide range of highly qualified personnel who are constantly updating their knowledge and, above all, are aware that the purpose of their work is to combat an illness that, if not opportunely treated, could lead to serious complications.
More than 75 milligrams of an effective drug in each packet of Oseltamivir is proof of the fact that the talent and will of many can win the toughest battles for life.